when a patient has already become ill. They do not involve testing the genetic make-up that a person is born with, and are not relevant to the plan for ‘early health’. Some genetic research into common diseases can still be useful, because small differences in risk caused by different genetic variants may give scientists important clues about the biological mechanisms of disease, even when they are useless to predict an individual’s risk. In addition, rare ‘familial’ forms of many common diseases exist, which can have a significant inherited component. But, for most diseases in most people, genetic ‘prediction and prevention’ is a poor health strategy. Thus, implementing ‘early health’ depends on companies’ gene tests avoiding scrutiny by the NHS’ National Screening Committee, which normally weighs up the benefits and harms of every screening programme, and avoiding regulation. GeneWatch UK Briefing April 2009 6
Lack of regulation of genetic tests “ Clearly, despite the possibility of developing genetic tests that are useful for some diseases in some contexts (e.g. in the presence of family history of disease), companies that are marketing genetic tests (especially direct-to-consumer genetic tests) have a financial incentive to exaggerate the importance of tests that may be about as effective as the Magic 8-Ball I keep on my desk ”. Dr Peter Kraft, Harvard, 2008. 75 “ There is insufficient scientific evidence to conclude that genomic profiles are useful in measuring genetic risk for common diseases or in developing personalized diet and lifestyle recommendations for disease prevention .” Janssens et al. (2008). 76 “ There is a growing business selling new genetic tests based on very preliminary research - the evidence is far too flimsy to be accepted by evidence-based medical practice. ” Sense about Science (2008). 77 No common genetic variants that meet medical screening criteria for the general population have been identified to date, however many tests for common genetic variants are already being marketed. This has the potential to harm health by: targeting the wrong health advice at the wrong people; confusing healthy-eating messages or advice to quit smoking; leading to the over-treatment of healthy people who may take unnecessary medication or supplements; undermining public health approaches and diverting resources from the social, environmental and economic changes that are needed to prevent ill-health. In Britain, no pre-market assessment is currently made of the clinical validity or utility of genetic tests that are available outside the NHS. In the USA, so-called ‘home brew’ tests (tests that are not marketed as kits to multiple laboratories) also receive no assessment. This means that ‘genetic information’ – combined with medicines, supplements, foods, skin creams, lifestyle advice and additional tests – can be marketed when it is not valid (for example, even when the gene plays no role in the claimed disease) or when it serves no useful purpose (for example, when the proposed intervention is no more effective or necessary in people with one genetic variant than with another).
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